PARIS (Reuters) – Valneva now expects a positive recommendation from the European Medicines Agency (EMA) in April for its VLA2001 COVID-19 candidate vaccine, the French vaccine maker said on Friday, compared to an earlier target for the end of March.
“Following such conditional approval, the company would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022,” said Valneva.
It cited a “a small set of additional questions” from the EMA as reason for the delay, adding it was set to respond within days.
In early February, the EMA flagged that it was unsure whether Valneva’s vaccine candidate could win approval by Easter, or mid-April.
Still, Valneva said in mid-February it was hoping for a recommendation by the end of March.
If approved, the shot would be Europe’s first inactivated whole-virus vaccine against COVID-19.
Valneva last November signed an agreement with the European Commission to supply 24.3 million doses in 2022. Further EU purchase options could boost total deliveries this year and next to up to 60 million doses.
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